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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004687-47 | EudraCT Number |
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This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.
This study is only being conducted in the EU and Canada
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | ABT-874 |
|
| B | Active Comparator | Methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-874 | Drug | 200 mg at week 0 and 4 and 100mg at week 8 and every 4 weeks there after administered as aSQ injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24 | Week 24 | |
| The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24 | Week 24 | |
| Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52 | Week 52 | |
| The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52 | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24 | Week 24 | |
| Changes from Baseline in the DLQI total score at Week 24 | Week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Kaul, MD | AbbVie | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 9904 | Graz | 8036 | Austria | |||
| Site Reference ID/Investigator# 11001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22169986 | Derived | Inzinger M, Weger W, Salmhofer W, Wolf P. Differential response of chronic plaque psoriasis to briakinumab vs. ustekinumab. Acta Derm Venereol. 2012 Jul;92(4):357-8. doi: 10.2340/00015555-1243. No abstract available. | |
| 22029980 | Derived | Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, Valdes JM. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med. 2011 Oct 27;365(17):1586-96. doi: 10.1056/NEJMoa1010858. |
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| Methotrexate | Drug | 5.0 to 25 mg weekly |
|
| Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52 |
| Week 52 |
| Changes from Baseline in the DLQI total score at Week 52 | Week 52 |
| Vienna |
| 1090 |
| Austria |
| Site Reference ID/Investigator# 12763 | Vienna | A-1030 | Austria |
| Site Reference ID/Investigator# 8022 | Brussels | 1200 | Belgium |
| Site Reference ID/Investigator# 13104 | Barrie | L4M 6L2 | Canada |
| Site Reference ID/Investigator# 13161 | Halifax | B3H 0A2 | Canada |
| Site Reference ID/Investigator# 11864 | Hamilton | L8N 1V6 | Canada |
| Site Reference ID/Investigator# 13223 | Québec | G1V 4X7 | Canada |
| Site Reference ID/Investigator# 13221 | Waterloo | N2J 1C4 | Canada |
| Site Reference ID/Investigator# 11381 | Aarhus | 8000 | Denmark |
| Site Reference ID/Investigator# 11841 | Copenhagen NV | 2400 | Denmark |
| Site Reference ID/Investigator# 8030 | Helsinki | 00029 HUS | Finland |
| Site Reference ID/Investigator# 8033 | Kuopio | 70211 | Finland |
| Site Reference ID/Investigator# 8021 | Lahti | 15850 | Finland |
| Site Reference ID/Investigator# 8026 | Turku | 20521 | Finland |
| Site Reference ID/Investigator# 11661 | Créteil | 94010 | France |
| Site Reference ID/Investigator# 11504 | Nice | 06200 | France |
| Site Reference ID/Investigator# 11161 | Paris | 75475 | France |
| Site Reference ID/Investigator# 10963 | Toulouse | 31059 | France |
| Site Reference ID/Investigator# 8025 | Berlin | 10117 | Germany |
| Site Reference ID/Investigator# 8024 | Frankfurt am Main | 60590 | Germany |
| Site Reference ID/Investigator# 8032 | Hamburg | D-20354 | Germany |
| Site Reference ID/Investigator# 8027 | Kiel | 24105 | Germany |
| Site Reference ID/Investigator# 8035 | Munich | D-80337 | Germany |
| Site Reference ID/Investigator# 8019 | Münster | 48149 | Germany |
| Site Reference ID/Investigator# 8023 | Tübingen | 72076 | Germany |
| Site Reference ID/Investigator# 13422 | Athens | 161 21 | Greece |
| Site Reference ID/Investigator# 13462 | Athens | 16121 | Greece |
| Site Reference ID/Investigator# 13461 | Thessaloniki | 54643 | Greece |
| Site Reference ID/Investigator# 12381 | Milan | 20161 | Italy |
| Site Reference ID/Investigator# 9583 | Modena | 41100 | Italy |
| Site Reference ID/Investigator# 8551 | Rome | 00133 | Italy |
| Site Reference ID/Investigator# 11701 | Amsterdam | 1105 AZ | Netherlands |
| Site Reference ID/Investigator# 8363 | Nijmegen | 6500 HB | Netherlands |
| Site Reference ID/Investigator# 13481 | Barcelona | 08916 | Spain |
| Site Reference ID/Investigator# 10702 | Madrid | 28006 | Spain |
| Site Reference ID/Investigator# 13163 | Seville | 41009 | Spain |
| Site Reference ID/Investigator# 8362 | Valencia | 46014 | Spain |
| Site Reference ID/Investigator# 8185 | Stockholm | 171 76 | Sweden |
| Site Reference ID/Investigator# 10203 | Geneva | 1211 | Switzerland |
| Site Reference ID/Investigator# 8020 | Zurich | 8091 | Switzerland |
| Site Reference ID/Investigator# 12401 | Aberdeen | AB25 2ZR | United Kingdom |
| Site Reference ID/Investigator# 8034 | Manchester | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C544528 | briakinumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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